Roche’s Tecentriq Wins FDA Nod for Additional Indication

Roche Holding AGRHHBY announced that the FDA has approved its immuno-oncology drug, Tecentriq (atezolizumab), for an additional indication. Tecentriq has been approved for the treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose disease has progressed during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.

With this approval, Tecentriq has become the first and only anti-PDL1 cancer immunotherapy to be approved by the FDA for the treatment of metastatic NSCLC.

We note that Tecentriq gained accelerated approval in the U.S. in May 2016 for the treatment of patients suffering from locally advanced or metastatic urothelial carcinoma, whose disease has progressed during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.

Roche is currently evaluating Tecentriq in a confirmatory phase III study (IMvigor 211), in comparison to chemotherapy, in patients whose bladder cancer has progressed on at least one prior platinum-containing regimen.

We are encouraged by the latest label expansion of Tecentriq. Per the American Cancer Society, more than 224,000 people are estimated to be diagnosed with lung cancer in 2016 in the U.S., with NSCLC accounting for 85% of these cases. Further, it has been estimated that about 60% of lung cancer diagnoses in the U.S. are made when the disease is in the most advanced stages.

Initial uptake of the drug has been encouraging. A label expansion should boost the commercial potential of the drug significantly.

Meanwhile, Tecentriq is being studied in more than 15 studies in lung cancer, including seven phase III studies in previously untreated (first-line) lung cancer. These studies are evaluating the use of Tecentriq alone or in combination with other treatments.

Tecentriq’s recent approval will intensify competition in the lung cancer space, which is already crowded by Bristol-Myers Squibb Company’s BMY Opdivo and Merck & Co., Inc.’s MRK Keytruda, both approved for the treatment of metastatic NSCLC.

Incyte’s earnings estimates for 2016 and 2017 were up a respective 10% and 2.8% over the last 60 days. The company has beaten earnings estimates thrice in the last four quarters with an average surprise of 335.16%.

Confidential from Zacks

Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report